Evaluation of the New Orleans Intervention for Infant Mental Health (BEST?)

University of Glasgow

Status: Completed

Conditions: Maltreated Infants

Treatments: Behavioral: FACS; Behavioral: GIFT

Study type: Interventional

Funder types: Other

Identifiers

NCT01485510

CZH/4/629

Details and patient eligibility

About

Early intervention for maltreated infants can improve mental and physical health throughout life and benefit families and society as a whole. The New Orleans Model provides intensive assessment and treatment for families of maltreated preschool children in foster care, with recommendations to court about adoption, or permanent return to birth families. The New Orleans Model appears to have led to better informed decisions about permanent placement and to better child mental health in Louisiana. The investigators propose an exploratory randomised controlled trial investigating the effectiveness of the New Orleans Model in the Scottish context, informing the development of an economic model to explore the potential cost-effectiveness. Families with a maltreated child under 5 years of age will be offered the New Orleans Model or "case management" i.e. quality assured services as usual, using random allocation. The investigators will measure outcome using well validated measures of parent-child interaction, cognition and attachment.

Full description

The first 5 months of this trial - from December 2011 to April 2012 - is an internal pilot or "implementation period". During this time we have fewer research staff, both services will just have started and we will only be collecting selected outcome measures. These will be the Principle Outcome Measure, the Infant-Toddler Social-Emotional Assessment (ITSEA), plus the Disturbance of Attachment Interview (DAI) and Parent-Infant Global Assessment of Functioning (PIR-GAS). We hope to include data from implementation period in our trial analysis, but if results are very different due to services "bedding in", we may not do so

Enrollment: 227 patients

Sex: All

Ages: 6 to 60 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All maltreated children placed in foster care, aged between 6 and 60 months, whose parents give informed opt-in consent

Exclusion criteria

• Children with profound learning disability

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

227 participants in 2 patient groups

Glasgow Infant and Family Team (GIFT)

Experimental group

Description:

A service developed by Charles Zeanah and colleagues in New Orleans, that aims to improve the mental health of maltreated infants.

Treatment:

Behavioral: GIFT

Family Assessment & Contact Service

Active Comparator group

Description:

A social-work based service that aims to assess maltreated children and make recommendations about their future care.

Treatment:

Behavioral: FACS